AltruBio moves forward with clinical development of Neihulizumab in Steroid-Refractory Acute Graft-versus-Host Disease after encouraging Phase 1a results
- Category: DNA RNA and Cells
- Published on Thursday, 02 July 2020 12:23
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Led by hemato-oncologist Dr. Paul J Martin of the Fred Hutchinson Cancer Research Center, this single-arm, open-label Phase 1 single dose, dose-finding study demonstrated a 77% (10/13 patients) response rate after a single dose of Neihulizumab treatment with 69% (9/13) of patients responding after 28 days.
REDWOOD CITY, CA, USA I July 01, 2020 I AltruBio Inc. http://www.altrubio.com, a clinical stage biotech company, presented its phase 1a findings of Neihulizumab, a biologic for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD), at European Hematology Association (EHA) annual conference in June 2020. Led by hemato-oncologist Dr. Paul J Martin of the Fred Hutchinson Cancer Research Center, this single-arm, open-label Phase 1 single dose, dose-finding study demonstrated a 77% (10/13 patients) response rate after a single dose of Neihulizumab treatment with 69% (9/13) of patients responding after 28 days.
The study Lead, Dr. Paul Martin, stated, “The results of this single dose study showed that Neihulizumab has an acceptable PK and safety profile in patients with SR-aGVHD involving the skin. In addition, the results showed evidence of clinical activity in 10/13 patients.”
Dr. Judy Chou, President & CEO of AltruBio Inc., was encouraged by the results stating, “The high response rate of Neihulizumab in this study encourages us to move this drug candidate forward. SR-aGVHD continues to be a significant unmet medical need and further treatment options are required.”
These results support continued testing of neihulizumab in patients with SR-aGVHD with multiple dosing to further assess safety and efficacy. The multiple dose phase of the trial is currently ongoing.
Neihulizumab is an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes chronically activated T cells. This mechanism has been evaluated in four autoimmune and inflammatory diseases and has demonstrated clinical proof of concept and safety in more than 100 patients with psoriasis and psoriatic arthritis. This study drug is currently in Phase 2 trials for the treatment of refractory ulcerative colitis and in Phase 1 trials for the treatment of SR-aGVHD, with encouraging results in patients that are refractory to available therapies. Phase 1 trial for the treatment of front-line acute GvHD is currently initiated.
About acute Graft-versus-Host Disease.
Acute GvHD is a major complication following an allogeneic HCT. Somewhere between 30 and 70 percent of transplant recipients develop acute GvHD. Standard first –line treatment is systemic, high-dose glucocorticoid, with around 50% response rate and are associated with clinically significant side effects. Patients who do not respond to corticosteroid treatment are considered steroid-refractory. SR-aGVHD is a significant unmet medical need and novel, effective treatments are urgently needed.
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About AltruBio Inc. (http://www.altrubio.com)
AltruBio is a privately held biotechnology company headquartered in the San Francisco Bay Area that is focused on developing novel antibody therapeutics for the treatment of immunological diseases with high unmet medical needs. Based on unique insights into immune tolerance and epitope dominance sciences, AltruBio’s pipeline includes two clinical stage product candidates: (i) Neihulizumab (AbGn-168H) an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes unwanted activated T cells with proof of mechanism in four autoimmune and inflammatory diseases, and (ii) AbGn-107, an antibody-drug conjugate (ADC) employing a unique enzyme cleavable hydrophilic self-immolative linker and targeting a gastrointestinal tumor antigen. AbGn-107 has demonstrated encouraging results in chemo-refractory gastric, pancreatic, colorectal and biliary cancers.